Bio-Processing Test Engineer at CPC in Roseville, Minnesota

Job Description:

Job Title: Bioprocessing Test Engineer

We are looking for a Bioprocessing Test Engineer to join our Fluidics, Analytical and Mechanical (FAM) Lab team, based in Roseville, MN. Reporting to the FAM Lab Manager, the Bioprocessing Test Engineer will work with both internal and external resources. This position performs research and testing of varying complexity on CPC and compatriot products to provide accurate and thorough data for engineering staff, customers and fellow employees.

Essential Job Responsibilities:

• Act as subject matter expert for many different methodologies and their relevant standards
  
  
  • Bioburden extraction methodologies
  
  
  • Subvisible particulate enumeration
  
  
  • LAL/BET
  
  
  • Microbial ingress
  
  
  
  


• Develops and validates new and existing methods for sterilization processes.


• Validating processes involving microorganisms.


• Identifies and implements new technologies and instrumentation


• Provide direction and training for staff as required


• Support root cause and problem-solving activities for failures

• Work closely with NPI department to characterize and validate new products


• Project management for testing (organize, plan, flow charts, timeline, monitor, review results, updates to retool team)


• Communicates test results; assists with analysis of data and writing of test reports related to test procedures and results.


• Maintains a clean, organized and safe work environment in all CPC labs


• Adheres to all safety regulations.


• Performs other job duties as assigned to meet business needs.

MinimumQualifications:

• Bachelor's degree in microbiology, biochemistry or related technical/scientific degree.


• 3+ years of related experience in wet lab Microbiology


• 3+ years in method development and validation strongly preferred


• Some project management experience


• Familiar with the following standards:
  
  
  • USP <62>, USP <85>, USP <788>
  
  
  • ISO13485, ISO9001
  
  
  • ASTM E3251-20 Ingress
  
  
  
  


• Must have microbiology experience plus expertise in the following:
  
  
  • Microbial test method validation
  
  
  • Microbial sampling and interpretation of ID
  
  
  • Microbial ingress testing
  
  
  
  


• Maintains current with research and best practices in microbiology, instrumentation and technologies
  
  

Preferred Qualifications:

• Master's degree in microbiology, biochemistry or related technical/scientific degree.


• 5+ years of related experience in wet lab Microbiology


• 5+ years in method development and validation strongly preferred


• Accomplished project manager


• Effective communicator with leadership potential


• Active in relevant industrial or academic forums pertaining to microbial ingress studies (i.e. medical packaging, biopharma, biofuels, etc.)

Supervisory Responsibilities:

• Daily task management for technicians and interns

Travel:

• Less than 5%

Physical Demands:

• The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


• The employee must frequently lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to stand, walk and/or stoop.

Work Environment:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


• While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts and vibration.


• The noise level in the work environment is usually moderate.
  
  

About CPC (Colder Products Company)
We are Colder Products Company, the industry leader in the design and manufacture of specialized quick disconnect couplings for the life sciences, industrial, and chemical handling markets. Used around the world in a broad range of applications, connection technologies from Colder Products Company allow flexible tubing to be quickly and safely connected and disconnected, reducing spills and increasing safety. Colder Products Company, a Dover company, is based in St. Paul with global offices and operations in Europe and Asia.